J&J Wins Blockbuster Approval to Market Xarelto for Stroke Prevention

The FDA has given Johnson & Johnson (NYS: JNJ) the green light to market Xarelto to prevent stroke among patients suffering from atrial fibrillation -- opening up a blockbuster market involving more than 2 million patients. Bayer, which holds ex-U.S. rights, has already estimated peak sales at close to $3 billion, and the treatment has the potential to work in the acute coronary syndrome area. J&J holds the U.S. rights to the drug.

"Atrial fibrillation can lead to the formation of blood clots, which can travel to the brain, blocking blood flow and causing a disabling stroke," said Dr. Norman Stockbridge, a director in the FDA's Center for Drug Evaluation and Research. "This approval gives doctors and patients another treatment option for a condition that must be managed carefully."

There are a couple of important catches to this approval, though. J&J did not get the right to boast that Xarelto is superior to warfarin, and the FDA added a black box warning against discontinuing the drug without talking it over with a physician.

Xarelto has already snagged an approval for preventing blood clots after orthopedic surgery, but that indication pales next to the $20 billion market that is emerging for therapies that can replace the problematic warfarin. Boehringer Ingelheim already won an approval for Pradaxa, giving it the first-to-market advantage. Pfizer (NYS: PFE) and Bristol-Myers Squibb (NYS: BMY) are not far behind with Eliquis.

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